Abdominal DiastasisHipoDiastasiNCT04238156
Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis
A study testing Hypopressive abdominal exercises in people with Abdominal Diastasis, run by Universidad de Córdoba at 1 site in Spain.
Trial summary
The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Abdominal Diastasis
- What is being tested?
- Hypopressive abdominal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2020to 20 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primiparous or multiparous
- abdominal diastasis previously diagnosed
- commitment to perform, at least, 80% of the exercises
- signed informed consent
Who cannot join
- BMI > 40 Kg/m2
- pelvic floor disorders before childbirth
- drugs with effects on continence or functional properties of the pelvic floor muscles
- treatment for abdominal diastasis in the last 6 months
- systemic disease that impairs pelvic floor physiology and urination
- menopause
- contraindications to the practice of physical exercise and physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypopressive Abdominal Exercise Effectiveness in Postpartum Abdominal Diastasis, Tone of the Transverse Muscle and the Pelvic Floor Muscles - Case Series
The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis.
Hypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. However, there is a lack of studies that determine its effectiveness and clinical utility.
Read more
The aim of the study will be to analyze the effects of Hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature.
A case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.
- Conditions
- Abdominal Diastasis
- Being tested
- Hypopressive abdominal exercises
- Keywords
- Postpartum, Hypopressive abdominal exercises, Pelvic floor muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive abdominal exercisesOther
Three sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hypopressive abdominal exercises | Experimental | Hypopressive abdominal exercises will be performed in basic postures (standing, sitting and supine position). In each posture, three slow cost-diaphragmatic respiration will be performed followed by an expiratory apnea and a rib cage opening, during 2 to 10 seconds, and an exhalation of 10 to 30 seconds. Each exercise will be repeated three times.
There will be 3 stages of application throughout the 12 intervention sessions, supervised by a physical therapist:
First stage: To explain the concept of hypopressive respiration and how to perform it.
Second stage: To explain and apply the hypopressive abdominal exercises: 1. Axial auto-elongation (reducing curvatures in the sagittal plane); 2. Cervical auto-elongation (chin toward the neck); 3. Moving forward of gravity axis; 4. Activation of the shoulder girdle (shoulder joint decoaptation); 5. Slight knee flexion; 6. Dorsal ankle flexion.
Third stage: To review and update all the exercises, increasing their intensity. Receives: Other: Hypopressive abdominal exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Diastasis - Baseline
Supraumbilical distance between the rectus abdominis
- Assessment tool: caliper (electronic, calibrated, precision: 1 mm)
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Pre-intervention
Abdominal Diastasis - post-intervention 1
Supraumbilical distance between the rectus abdominis
- Assessment tool: caliper (electronic, calibrated, precision: 1 mm)
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Immediately after the intervention
Abdominal Diastasis - post-intervention 2
Supraumbilical distance between the rectus abdominis
- Assessment tool: caliper (electronic, calibrated, precision: 1 mm)
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: One month after the intervention
Abdominal Diastasis - post-intervention 3
Supraumbilical distance between the rectus abdominis
- Assessment tool: caliper (electronic, calibrated, precision: 1 mm)
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Two months after the intervention
Secondary outcomes (16)
Abdominal tonometry - Baseline
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Pre-intervention
Perineal tonometry - Baseline
Tonometric evaluation on the perineal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Pre-intervention
Waist circumference - Baseline
Waist circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: minimum perimeter
Measured: Pre-intervention
Chest circumference - Baseline
Chest circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: maximum perimeter
Measured: Pre-intervention
Abdominal tonometry - post-intervention 1
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Immediately after the intervention
Perineal tonometry - post-intervention 1
Tonometric evaluation on the perineal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Immediately after the intervention
Waist circumference - post-intervention 1
Waist circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: minimum perimeter
Measured: Immediately after the intervention
Chest circumference - post-intervention 1
Chest circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: maximum perimeter
Measured: Immediately after the intervention
Abdominal tonometry - post-intervention 2
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: One month after the intervention
Perineal tonometry - post-intervention 2
Tonometric evaluation on the perineal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: One month after the intervention
Waist circumference - post-intervention 2
Waist circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: minimum perimeter
Measured: One month after the intervention
Chest circumference - post-intervention 2
Chest circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: maximum perimeter
Measured: One month after the intervention
Abdominal tonometry - post-intervention 3
Tonometric evaluation on the white line (linea alba) and the abdominal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Two months after the intervention
Perineal tonometry - post-intervention 3
Tonometric evaluation on the perineal muscles
- Assessment tool: (MyotonPro (R))
- Subject position: supine
- Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Measured: Two months after the intervention
Waist circumference - post-intervention 3
Waist circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: minimum perimeter
Measured: Two months after the intervention
Chest circumference - post-intervention 3
Chest circumference
- Assessment tool: tape measure (flexible, precision: 1mm)
- Subject position: standing
- Localization: maximum perimeter
Measured: Two months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Jan 2020
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal DiastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Alburquerque-Sendín, Universidad de Córdoba
- Investigators
- Daiana Priscila Rodrigues-de-Souza, PhD, Study director, Universidad de CórdobaMiriam Ramírez Jiménez, Phys Ther, Principal investigator, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238156
- Sponsor's protocol ID
- HipoDiastasis4073-2018
- Acronym
- HipoDiastasi
- Status last verified
- Jul 2020
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypopressive Abdominal Exercise Effectiveness in Postpartum Abdominal Diastasis, Tone of the Transverse Muscle and the Pelvic Floor Muscles - Case Series
- ClinicalTrials.gov ID
- NCT04238156
- Acronym / sponsor ID
- HipoDiastasi / HipoDiastasis4073-2018
- Conditions
- Abdominal Diastasis
- Keywords
- Postpartum, Hypopressive abdominal exercises, Pelvic floor muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis.
Hypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. However, there is a lack of studies that determine its effectiveness and clinical utility.
The aim of the study will be to analyze the effects of Hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature.
A case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypopressive abdominal exercises | Experimental | Other: Hypopressive abdominal exercisesHypopressive abdominal exercises will be performed in basic postures (standing, sitting and supine position). In each posture, three slow cost-diaphragmatic respiration will be performed followed by an expiratory apnea and a rib cage opening, during 2 to 10 seconds, and an exhalation of 10 to 30 seconds. Each exercise will be repeated three times. There will be 3 stages of application throughout the 12 intervention sessions, supervised by a physical therapist: First stage: To explain the concept of hypopressive respiration and how to perform it. Second stage: To explain and apply the hypopressive abdominal exercises: 1. Axial auto-elongation (reducing curvatures in the sagittal plane); 2. Cervical auto-elongation (chin toward the neck); 3. Moving forward of gravity axis; 4. Activation of the shoulder girdle (shoulder joint decoaptation); 5. Slight knee flexion; 6. Dorsal ankle flexion. Third stage: To review and update all the exercises, increasing their intensity. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- primiparous or multiparous
- abdominal diastasis previously diagnosed
- commitment to perform, at least, 80% of the exercises
- signed informed consent
Key exclusion criteria (7 listed)
- BMI > 40 Kg/m2
- pelvic floor disorders before childbirth
- drugs with effects on continence or functional properties of the pelvic floor muscles
- treatment for abdominal diastasis in the last 6 months
- systemic disease that impairs pelvic floor physiology and urination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypopressive abdominal exercisesThree sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes. | Other | Hypopressive abdominal exercises |
Primary outcome
Abdominal Diastasis - Baseline
Time frame: Pre-intervention
Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Abdominal Diastasis - post-intervention 1
Time frame: Immediately after the intervention
Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Abdominal Diastasis - post-intervention 2
Time frame: One month after the intervention
Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
Abdominal Diastasis - post-intervention 3
Time frame: Two months after the intervention
Supraumbilical distance between the rectus abdominis * Assessment tool: caliper (electronic, calibrated, precision: 1 mm) * Subject position: supine * Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical
16 secondary outcomes
Abdominal tonometry - Baseline
Time frame: Pre-intervention
Perineal tonometry - Baseline
Time frame: Pre-intervention
Waist circumference - Baseline
Time frame: Pre-intervention
Chest circumference - Baseline
Time frame: Pre-intervention
Abdominal tonometry - post-intervention 1
Time frame: Immediately after the intervention
Perineal tonometry - post-intervention 1
Time frame: Immediately after the intervention
Waist circumference - post-intervention 1
Time frame: Immediately after the intervention
Chest circumference - post-intervention 1
Time frame: Immediately after the intervention
Abdominal tonometry - post-intervention 2
Time frame: One month after the intervention
Perineal tonometry - post-intervention 2
Time frame: One month after the intervention
Waist circumference - post-intervention 2
Time frame: One month after the intervention
Chest circumference - post-intervention 2
Time frame: One month after the intervention
Abdominal tonometry - post-intervention 3
Time frame: Two months after the intervention
Perineal tonometry - post-intervention 3
Time frame: Two months after the intervention
Waist circumference - post-intervention 3
Time frame: Two months after the intervention
Chest circumference - post-intervention 3
Time frame: Two months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daiana Priscila Rodrigues-de-Souza, PhD study director
Universidad de Córdoba
Miriam Ramírez Jiménez, Phys Ther principal investigator
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive abdominal exercises in people with Abdominal Diastasis, run by Universidad de Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Diastasis - Baseline (time frame: Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.